[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55493-55494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8020]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Comment Request

    In compliance with the requirement for opportunity for public 
comment on proposed data collection projects (section 3506(c)(2)(A) of 
Title 44, United States Code, as amended by the Paperwork Reduction Act 
of 1995, Pub. L. 104-13), the Health Resources and Services 
Administration (HRSA) publishes periodic summaries of proposed projects 
being developed for submission to the Office of Management and Budget 
(OMB) under the Paperwork Reduction Act of 1995. To request more 
information on the proposed project or to obtain a copy of the data 
collection plans and draft instruments, call the HRSA Reports Clearance 
Officer at (301) 443-1129.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.

Proposed Project: The Stem Cell Therapeutic Outcomes Database--(New)

    The Stem Cell Therapeutic and Research Act of 2005 provides for the 
collection and maintenance of human blood stem cells for the treatment 
of patients and research. The Health Resources and Services 
Administration's (HRSA), Healthcare Systems Bureau (HSB), is 
establishing the Stem Cell Therapeutic Outcomes Database. Operation of 
this database necessitates certain record keeping and reporting 
requirements in order to perform the functions related to hematopoietic 
stem cell transplantation under contract to HHS. The Act requires the 
Secretary to contract for the collection and maintenance of information 
related to patients who have received stem cell therapeutic products 
and to do so using a standardized, electronic format. Data will be 
collected from transplant centers in a manner similar to the data 
collection activities conducted by The Center for International Blood 
and Marrow Transplant Research (CIBMTR) and will be used for ongoing 
analysis of transplant outcomes. HRSA will use the information in order 
to carry out its statutory responsibilities. Information is needed to 
monitor the clinical status of transplantation, and to provide the 
Secretary with an annual report of transplant center-specific survival 
data.
    The estimate of burden is as follows:

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                                    Number of     Responses per       Total         Hours per      Total burden
         Record keeping             responses      respondent       responses       response          hours
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Baseline Patient/Day of                     250              40           8,000            2.25         18,000
 Transplant Data...............
Product Receipt/Analysis/                   250              40           8,000            1             8,000
 Preparation Data..............
100-Day Post-Transplant Data...             250              40           8,000            2.25         18,000
6-Month Post Transplant Data...             250              28           5,538            2.25         12,460.5
12-Month Post-Transplant Data..             250              22           4,308            2.25          9,693
Annual Post-Transplant Data                 250              40           8,000            2.25         18,000
 (year two and beyond).........
Death Information..............             250              25           4,923            0.5           2,461.5
                                --------------------------------------------------------------------------------
    Total......................             250  ..............          46,769  ..............         86,615
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[[Page 55494]]

    Send comments to Susan G. Queen, Ph.D., HRSA Reports Clearance 
Officer, Room 10-33, Parklawn Building, 5600 Fishers Lane, Rockville, 
MD 20857. Written comments should be received within 60 days of this 
notice.

    Dated: September 15, 2006.
Cheryl R. Dammons,
Director, Division of Policy Review and Coordination.
[FR Doc. 06-8020 Filed 9-21-06; 8:45 am]
BILLING CODE 4165-15-P